Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Sponsor

Surgalign Spine Technologies (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02074761

Collaborator

(none)

250

Enrollment

Locations

69.8

Anticipated Duration (Months)

11.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.

Condition or Disease	Intervention/Treatment	Phase
Sacroiliac Joint Dysfunction	Device: SImmetry

Detailed Description

This is a prospective, non-randomized post market study designed to evaluate fusion and pain reduction following the use of the SImmetry System. This study will be conducted at up to 40 sites and 250 total subjects will be enrolled and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Actual Study Start Date :

Jan 6, 2015

Actual Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
SImmetry Implant Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.	Device: SImmetry The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion.

Arm

Intervention/Treatment

SImmetry Implant

Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.

Device: SImmetry

The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion.

Outcome Measures

Primary Outcome Measures

SI Joint Fusion [12 months]
Fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. This will be assessed by an independent core laboratory
SI Joint Pain Reduction [6 Months]
SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.

Secondary Outcome Measures

SI Joint Pain Reduction [12 months]
SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.
Disability [6 months]
Functional ability as determined by the Oswestry Disability Index
Quality of Life [6 months]
Quality of life as determined by EQ-5D

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

At least three positive provocative tests for SIJ pain
Non-operative management of SIJ pain for ≥ 6 months prior to surgery
At least one positive diagnostic SIJ injection resulting in a ≥ 50% decrease in pain
VAS back pain score of ≥ 60 mm
The subject is at least 18 years of age

Key Exclusion Criteria:

Trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit, or pelvic soft tissue or bony tumors
Pregnant or is planning on becoming pregnant in the next two years
Chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview.
Receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain
History of significant emotional or psychosocial disturbance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The CORE Institute	Phoenix	Arizona	United States	85023
2	BASIC Spine	Newport Beach	California	United States	92660
3	Kaiser Permanente	Oakland	California	United States	94611
4	Rocky Mountain Spine Clinic	Lone Tree	Colorado	United States	80124
5	Orthopaedic Clinic of Daytona Beach	Daytona Beach	Florida	United States	32117
6	Central Florida Neurosurgery Institute	Orlando	Florida	United States	32801
7	Flagler Hospital	Saint Augustine	Florida	United States	32086
8	Gainesville Physical Therapy	Gainesville	Georgia	United States	30506
9	DK Orthopaedics	Crown Point	Indiana	United States	46307
10	SBA Medical Center	El Dorado	Kansas	United States	67042
11	Western Michigan University Homer Stryker MD School of Medicine	Kalamazoo	Michigan	United States	49008
12	Tristate Brain and Spine Institute	Alexandria	Minnesota	United States	56308
13	Essentia Health	Duluth	Minnesota	United States	55805
14	Regional Brain and Spine	Cape Girardeau	Missouri	United States	63701
15	Portland Pain and Spine	Portland	Oregon	United States	97229
16	Medical University of South Carolina	Charleston	South Carolina	United States	29425
17	Black Hills Orthopedic & Spine Center	Rapid City	South Dakota	United States	57702
18	Azalea Orthopedics	Tyler	Texas	United States	75701
19	University of Utah	Salt Lake City	Utah	United States	84108
20	Bellevue Bone and Joint Physicians	Bellevue	Washington	United States	98004
21	Fourth Corner Neurological Associates	Bellingham	Washington	United States	98225
22	Northwest Orthopaedic Specialists	Spokane	Washington	United States	99208